FDA grants breakthrough designation to MM-120 for generalized anxiety disorder
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Key takeaways:
- MM-120 demonstrated clinically and statistically significant reductions in anxiety compared with placebo at 12 weeks.
- Phase 3 clinical trials are expected to begin in the second half of 2024.
The FDA has granted breakthrough designation to MM-120 for the treatment of generalized anxiety disorder, according to a press release from MindMed.
The company also announced that its phase 2b study of MM-120 (lysergide D-tartrate) in generalized anxiety disorder (GAD) met its key secondary endpoint, demonstrating a 7.7-point improvement over placebo at 12 weeks, with a 65% clinical response rate and a 48% clinical remission rate, according to the release.
Additionally, MM-120 was generally well-tolerated, with mostly transient and mild-to-moderate adverse events occurring on dosing day.
“The FDA’s decision to designate MM-120 as a breakthrough therapy for GAD and the durability data from our phase 2b study provide further validation of the important potential role this treatment can play in addressing the huge unmet need among individuals living with GAD,” MindMed Director and CEO Robert Barrow said in the release.
The company plans to hold an end-of-phase 2 meeting with the FDA in the first half of 2024 and initiate phase 3 clinical trials in the second half of 2024.